Status:
RECRUITING
Benfit of Remote Monitoring in Pacemaker
Lead Sponsor:
Yonsei University
Conditions:
Pacemaker Implanted Patients
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Modern CIEDs are equipped with remote monitoring (RM) technology, which provides automatic transmissions of diagnostics and technical data from the implanted devices to the attending physician. RM has...
Detailed Description
* Study Objective Primary study objective The primary objective of this non-inferiority, prospective trial in Korean population is to confirm that the proportion of patients who experienced at least o...
Eligibility Criteria
Inclusion
- Age: 18-80 years
- Patients with permanent pacemaker with SenseAbility feature \& RM
- Ability to provide informed consent and to complete the study and required follow-up ④ Those who refuse to use remote monitoring system or who live in an environment where remote monitoring system cannot be utilized.
- Patient who refuse to use or expected to use less than 75% of remote monitoring system.
Exclusion
- Severe hepatic and renal insufficiency (AST or ALT ≥ three times of normal upper limit; SCr \> 3.5 mg/dl or Ccr \< 30ml/min)
- Thyroid gland dysfunction
- Pregnancy ④ Malignant tumor
- Severe organic heart disease (such as moderate to severe mitral regurgitation, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease)
- Life expectancy \< 12 months ⑦ Patients unable or unwilling to cooperate in the study procedures.
Key Trial Info
Start Date :
January 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT06043570
Start Date
January 17 2023
End Date
December 1 2027
Last Update
September 21 2023
Active Locations (1)
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1
Severance Cardiovascular Hospital Yonsei University
Seoul, South Korea